IMFINZI 500 MG/10 ML

Indications

• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Other PD-L1 expressing malignancies

Dosage

Children: null

Adults: 500 mg every 3 weeks for 4 doses, then 1 g every 6 weeks from week 13 onwards, with adjustments based on side effects and infusion-related reactions.

Mechanism of action

Durvalumab binds to PD-L1, preventing its interaction with PD-1 and CD80 receptors. This action enhances T-cell activation and proliferation, promoting a stronger immune-mediated response against tumor cells.

Pharmacodynamics

The binding of Durvalumab to PD-L1 interrupts the inhibitory signals that normally dampen T-cell responses. This mechanism leads to increased T-cell activity against tumor cells, which can result in tumor regression. Clinical studies have shown improved overall survival rates in patients with PD-L1 expressing tumors treated with Durvalumab.

Pharmacokinetics

Durvalumab exhibits a biphasic pharmacokinetic profile, with a distribution half-life of approximately 12-20 days and an elimination half-life of around 18 days. It is administered via intravenous infusion, and its pharmacokinetics may be influenced by factors such as patient-specific characteristics and co-administered therapies. Durvalumab is primarily eliminated through a combination of target-mediated drug disposition and non-specific clearance.

Adverse effects

• Adrenal insufficiency
• Anaemia
• Arthralgia
• Autoimmune haemolytic anaemia
• Chills
• Durvalumab-related infusion reaction
• Diarrhoea
• Enterocolitis
• Haemorrhagic fever
• Gastrointestinal disorders
• Hyperthyroidism
• Hypertransaminasaemia
• Hypothyroidism
• Myalgia
• Nausea
• Pancreatitis

Precautions

• History of severe or life-threatening cutaneous adverse reactions associated with other immunostimulant antineoplastic drugs
• Patients who receive an allogeneic haematopoietic stem cell transplant before or after durvalumab treatment may be at an increased risk of transplant-related complications and should be closely monitored
• Increased risk of rejection in solid organ transplant recipients

Pregnancy

Avoid-limited information available.

Breast-feeding

Avoid during treatment and for at least 4 months after last treatment-no information available.

Storage

Store in a refrigerator (2–8°C) and protect from light-consult product literature for storage conditions after dilution.

Formulations

• Solution for infusion, 500 mg/10 mL concentrate

Dosage

Children: Refer to specific product information as dosages vary based on the formulation and indication.

Adults: Refer to specific product information as dosages vary based on the formulation and indication.

Mechanism of action

Monohydratea typically functions by providing increased solubility for other compounds, which facilitates their absorption in the gastrointestinal tract. This mechanism is particularly important for drugs that are poorly soluble in their anhydrous forms.

Pharmacodynamics

The pharmacodynamic profile of monohydratea is largely dependent on its role as a carrier for other active ingredients. It does not exhibit significant pharmacological activity on its own, but by improving the solubility and stability of co-administered drugs, it can enhance their therapeutic effects.

Pharmacokinetics

The pharmacokinetics of monohydratea is characterized by its rapid dissolution and subsequent absorption when administered orally. It is generally well-tolerated, with minimal systemic effects. The elimination of any active compounds associated with it follows standard metabolic and excretory pathways, typically involving renal clearance.

Pregnancy

Safety in pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution is advised when administering to breastfeeding mothers, as it is unclear whether the drug is excreted in human milk.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Indications

• Emulsifying agent in drug formulations
• Stabilizer for parenteral preparations
• Solubilizer for hydrophobic drug compounds
• Ingredient in topical formulations

Dosage

Children: Refer to specific product guidelines, as dosing varies based on formulation and intended use.

Adults: Refer to specific product guidelines, as dosing varies based on formulation and intended use.

Mechanism of action

Polysorbate functions primarily as an emulsifying agent. It reduces the surface tension between immiscible liquids, allowing them to mix more easily. This property is particularly useful in stabilizing emulsions and suspensions, facilitating the delivery of active pharmaceutical ingredients in various formulations.

Pharmacodynamics

Polysorbate does not exert pharmacological effects in the traditional sense, as it does not bind to specific receptors to elicit a physiological response. Instead, it plays a crucial role in modifying the physical properties of drug formulations, thereby enhancing drug delivery and absorption. Its ability to solubilize drugs enhances their bioavailability, particularly for poorly soluble compounds.

Pharmacokinetics

Polysorbate is generally considered to be non-toxic and is not absorbed to a significant extent when administered orally. It is metabolized by the liver and excreted primarily through the gastrointestinal tract. The pharmacokinetic profile may vary depending on the route of administration and the specific formulation in which it is used.

Adverse effects

• Allergic reactions
• Skin irritation
• Gastrointestinal disturbances

Precautions

• Use cautiously in patients with known allergies to polysorbates or related compounds
• Monitor for allergic reactions in susceptible individuals

Pregnancy

Polysorbate is generally considered safe for use during pregnancy, but consult with a healthcare provider for specific cases.

Breast-feeding

Polysorbate is considered safe during breastfeeding, but consult with a healthcare provider for individual advice.

Storage

Store at room temperature, away from direct sunlight and moisture.

Formulations

• Polysorbate 20
• Polysorbate 80